January 2, 2021

Important COVID Vaccine Information

 

In the last few weeks, I received 2 e-mails from my dear friend Mike Hendrickson, who has spent numerous hours researching the issues with the COVID vaccine.  In this post is the link from his first e-mail detailing what he has found.  It is lengthy and quite detailed and scientific, so I encourage you to take the time to read the whole thing.  I will post his second link in the next blog. 

For myself, I do not plan on taking the vaccine, as there are too many inconsistencies there, and I value the good health that I currently enjoy and choose not to be a part of this global medical experiment.  In addition to Mike’s research, there is plenty of information out there on alternative media to suggest nefarious agendas at play.  Certainly “follow the money” might be one of them!

I would have rather seen our billions of tax payer money go to teaching people how to boost their immune systems, and creating effective treatments once one gets sick.  Hydroxychloroquine, vitamin D3, zinc and IV vitamin C come to mind, in addition to plenty of sunshine and moderate exercise outside every day.  Of course, the pharmaceutical companies can’t make a big profit on those.  

Keep in mind that I am not giving out any medical recommendations or diagnoses here.  These are just my personal opinions, and it is entirely up to you to decide how you would like to proceed.  

I have been going round and round trying to figure out how to put a link to his articles here.  Instead, here is the whole first article. 

You can contact Mike, who goes by Misha these days, at mikenlori9@gmail.com

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mRNA RESEARCH EXCERPTS (bold has been added for emphasis)     [Indicates author comments or explanations added]

Distribution with permission only, please!

Pfizer-BioNTech FDA Briefing Document, December 10, 2020

Here is the document submitted to FDA:  https://www.fda.gov/media/144245/download

The executive summary of the FDA proposal states on page 10: “…it is reasonable to believe that the Pfizer-BionTech COVID-19 vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older…”

 PHG (health policy think tank), University of Cambridge, England

What are RNA vaccines and how do they work?

Conventional vaccines usually contain inactivated disease-causing organisms or proteins made by the pathogen (antigens), which work by mimicking the infectious agent. They stimulate the body’s immune response, so it is primed to respond more rapidly and effectively if exposed to the infectious agent in the future.

RNA vaccines use a different approach that takes advantage of the process that cells use to make proteins: cells use DNA as the template to make messenger RNA (mRNA) molecules, which are then translated to build proteins. An RNA vaccine consists of an mRNA strand that codes for a disease-specific antigen. Once the mRNA strand in the vaccine is inside the body’s cells, the cells use the genetic information to produce the antigen. This antigen is then displayed on the cell surface, where it is recognised by the immune system. [That this technology would be tested on humans in only a short-term test period before mass inoculation is distressing (to me).]

Journal of American Medical Association, September 3, 2020

Despite the unprecedented speed, mRNA vaccines are clinically unproven. No commercially available vaccines use the platform and, until now, it hasn’t been tested in large-scale human trials. With COVID-19, that’s all set to change. Experts said in interviews that if the technology pans out, the pandemic could help to usher in a new plug-and-play approach to vaccinology.

Preexisting immunity could explain why a non–replicating viral vector COVID-19 candidate from CanSino Biologics Inc and several Chinese institutions elicited less-than-impressive neutralizing antibody levels in a phase 1 trial. Preexisting neutralizing antibodies to the vector, the human adenovirus 5, known as Ad5, ranges from up to 69% in the US to 80% in Africa. Of additional concern, Offit [University of Pennsylvania vaccinology professor Paul Offit, MD]said in an August livestream, more than a decade ago, men with preexisting Ad5 immunity had an increased risk of acquiring HIV infection after receiving an experimental Ad5-vectored HIV vaccine.[The point is that risk of an AE (Adverse Reaction) is increased if one has a “natural” immunity to a virus.]

The first 4 COVID-19 vaccine developers with published clinical trial data all used either a non–replicating adenovirus or mRNA platform. The US government is betting on some of these new technologies. Under the auspices of its Operation Warp Speed vaccine development initiative, it has already purchased hundreds of millions of doses of ChAdOx1 nCoV-19, mRNA-1273, BNT162b2, and an investigational non–replicating viral vector vaccine in early trials from Johnson & Johnson–owned Janssen Pharmaceutical Companies, as well as other candidates. Doses should be standing by if or when any of these are approved.

Tolerability could be another issue. “People will have to know that they may have some local reactions or feel like they’re a little under the weather for a day or so after the vaccine,” said Edwards [Kathryn Edwards, MD], scientific director of the Vanderbilt Vaccine Research Program, who is among the independent experts monitoring investigational COVID-19 vaccine safety. She and others said that, as with any new pharmaceutical product, phase 3 studies could also reveal more serious safety concerns and unexpected adverse effects could emerge later. [However, safety cannot be assured without a long-term trial because many AEs don’t emerge immediately.]

Speaking at the July 27 media briefing, Collins[National Institutes of Health (NIH) Director Francis Collins, MD, PhD]addressed concerns: “Yes, we’re going fast. But, no, we are not going to compromise safety or efficacy.” Experts say several factors argue for mRNA vaccines’ safety. For one, mRNA can’t cause an infection. It also doesn’t enter the cell’s nucleus, so the chance of its integration into human DNA is believed to be very low. In addition, the body breaks down mRNA and its lipid carrier within a matter of hours, assuaging some concerns about long-term risks. [I would want a lot more than “arguing” for safety. Also, integration into DNA could be a disaster because it would be irreversible and could even then link genetically to future generations of those affected – we need more assurance than “believed to be”.]

Weissman [Drew Weissman, MD, PhD, researches mRNA vaccines at the University of Pennsylvania Perelman School of Medicine] is trying to develop a more potent second-generation mRNA vaccine that protects with a single shot. He’s also set his sights on a universal coronavirus vaccine using the genetic platform. “We’ve had 3 coronavirus epidemics in the past 20 years,” he said. “The next time this happens, we’ll have a vaccine already made, ready to be shipped out and used very quickly to prevent the pandemic from taking over.”[So, in the interest of science, we go at warp speed? what about the safety for the present?]

Before COVID-19, his team was working on mRNA flu vaccines, as well as candidates for genital herpes and HIV. Influenza viruses acquire variations from season to season, making them excellent candidates for a rapid “vaccine on demand” platform. [It seems to be lost on medicine that there are natural ways to protect yourself from flu, such as vitamin C, vitamin D and zinc; as well as essential oils and colloidal silver which are powerful antivirals. Also, see this important antidote, ivermectin, presented on February 8, 2020 by Doctor Pierre Kory, University of Wisconsin, before Senate Committee, “State of the Pandemic and Development of Outpatient Treatments” (short video): https://www.brighteon.com/f81d427b-aa7d-4da6-a94c-64251e3c3f69]

A comment on the article from Giuliano Ramadori, Professor of Medicine | University Clinic, Internal Medicine, Göttingen, Germany [numbers (4) through (7) are his references to his research sources]: The measurement of such antibodies in the actual COVID-19-vaccine-studies should however transmit the hope that the induced antibodies will prevent SARS-CoV-2-infection. This can only be demonstrated by showing real prevention in a large phase III-study. After approval of the vaccine this should be accepted by all components of the society (White, Black, Hispanic, Asian). As it is, however, the participants in ongoing trials are almost exclusively white (4,5), similar to some influenza vaccine trials(6).The trials seem to exclude the majority of those people who are mainly hit by the infection and therefore less willing to accept vaccination (7). [Early small studies may have been mostly white but I don’t believe it is true of the large group studies; however, children were NOT included in the large double-blind studies.]

New England Journal of Medicine, July 14, 2020, article by panel of 12 doctors on the study of the Moderna mRNA-1273 vaccine of healthy student group at Vanderbilt University

[Adverse Event = An unexpected medical problem that happens during treatment with a drug or other therapy. Source: National Cancer Institute]

 

The 45 enrolled participants [15 in each of three dosage groups] received their first vaccination between March 16 and April 14, 2020 (Fig. S1). Three participants did not receive the second vaccination, including one in the 25-μg group [low dose]who had urticaria [skin reaction such as hives] on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits.[Demographics: mostly white participants. Also, note that they elected to exclude the 3 from the second vaccination who had either a reaction or were suspected of having the virus after the first vaccination.]

 No serious adverse events were noted [during the trial], and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.

 After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group; all were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.[Total of 86% had adverse events after second shot! Some severe!]

 None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever; one of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe.

 Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site.

 The American Association for the Advancement of Science, Derek Lowe,October 21, 2020

 Lowe quotes the FDA in his article as follows: “It is FDA’s expectation that, following submission of an EUA request and issuance of an EUA, a sponsor would continue to collect placebo-controlled data in any ongoing trials for as long as feasible and would also work towards submission of a Biologics License Application (BLA) as soon as possible. FDA’s recommendations regarding the safety and effectiveness data and information outlined below are essential to ensure that clinical development of a COVID-19 vaccine has progressed far enough that issuance of an EUA for the vaccine would not interfere with the ability of an ongoing Phase 3 trial to demonstrate effectiveness of the vaccine. . .”

“As long as feasible” is a well-crafted way of putting it. But we need to ask just how long that might be. You can see from the latter part of the quote that one of the considerations for issuing an EUA at all will be whether it might fatally disrupt the ongoing Phase III, and indeed, the FDA goes on to say that they don’t consider a vaccine EUA itself as grounds for unblinding. This leads us to the various clinical trial designs and interim data analyses, and how they fit in with an EUA request. It’s important to understand what the interim data readouts are designed to be able to say, which (translated into English from statistics) is something like “the distribution of coronavirus cases observed so far is not inconsistent with the vaccine having an eventual efficacy at the end of the trial of at least X per cent, at a certain pre-defined confidence level”. This sounds rather less definitive than what I think the general public might imagine the unblinding of clinical trial data looks like, and I should also add that it can take longer than you’d think (once you have the unblinded data) even to be able to say that much. This is not like rubbing off a lottery scratch ticket, that’s for sure. Rarely does a trial read out in a way that you look at the raw data and say “Holy guacamole, I think that stuff kicked butt”, although it should be said that obvious butt-kickings in the other direction are somewhat more common. [Meaning that adverse reactions are an important issue!]

We may get into a situation where an interim readout of the data show that a vaccine may well be working, but that granting an immediate EUA has a real danger of blowing the statistics for the complete trial. That is truly the worst outcome: ending up with something that might be useful, but being unable (despite all the time and money and effort) to be able to say if it really is. We’ve got to avoid that.

An additional problem is that I strongly suspect that many participants across all the US trials have a good idea of whether they’re in the placebo group or not. [That would mean that the trial has been botched scientifically because the double-blind requirement would not have been met; to have been met, those receiving the placebo cannot know that they are receiving it, otherwise the test for efficacy of the drug is invalid.]

Quoting FDA: “The placebo-controlled Phase III COVID-19 trials already include at least 30,000 participants, and there will be little acceptance of uncertainty about the efficacy of a vaccine to prevent a life-threatening disease.”

American Association for the Advancement of Science, Jon Cohen, October 14, 2020

Success in the push to find a COVID-19 vaccine at record-breaking speed could hand the world a new problem. The first vaccine to cross the finish line might be only marginally effective, yet it could become the enemy of the good—or even the great—candidates in the wings by disrupting ongoing studies.

In all likelihood, the U.S. Food and Drug Administration (FDA) or other regulators will issue the first COVID-19 vaccine approval or emergency use authorization (EUA) for one vaccine while many other candidates have clinical trials still underway or in the planning. [This happened on December 10, 2020.Note that an EUA is not even close to an approval. We will discuss this further in the next research.] At that point, ongoing studies of any vaccine—including that first one—could become unethical because half the participants would get a placebo, at a time a vaccine with established efficacy will be available. “It’s a very vexing issue,” says Christine Grady, who heads the bioethics department at the National Institutes of Health (NIH) Clinical Center, which organized a “grand rounds” webinar on the challenges last week.

Participants in the NIH [National Institute of Health] webinar agreed that the first EUA for a COVID-19 vaccine will change the landscape for that vaccine’s phase III trial and others. Should the blinded trial continue, to make sure that the early benefits pan out over a longer period of time, or should people in the placebo group immediately receive the vaccine? What if stopping the initial trial early reduces its ability to detect rare side effects, assess how long protection lasts, or compare the vaccine’s efficacy in the elderly versus young adults?

NY Times article, Carl Zimmer, November 20, 2020 (updated December 4, 2020)

A 95 percent efficacy is certainly compelling evidence that a vaccine works well. But that number doesn’t tell you what your chances are of becoming sick if you get vaccinated. And on its own, it also doesn’t say how well the vaccine will bring down Covid-19 across the United States.

[He goes on to show the calculation. There were 43,661 in the study and 170 had gotten sick when the study stopped, which is significantly less than 1%.  162 of those who got sick were in the placebo group and 8 in the vaccinated group. They then divide 162 by 170 to get 95% efficacy. Assuming the two groups were divided equally with about 21,830 in each group, the percentage of people who got sick in the placebo group (162 divided by 21,830 is still less than 1%).]

Dr. Sin Hang Lee and Informed Consent Action Network have filed a petition with the FDA to suspend

“BusinessWire” reported on December 7, 2020:A recent review of a COVID-19 PCR test, which was signed by 22 international scientists, emphatically stated:“To determine whether the amplified products are indeed SARS-CoV-2 genes, biomolecular validation of amplified PCR products is essential. For a diagnostic test, this validation is an absolute must.

The major reason for petitioning the FDA for a stay of action is that the Phase 2/3 clinical trial of the Pfizer vaccine used a presumptive RT-qPCR diagnostic test. This test is acknowledged by the medical science community to generate high rates of false-positive results among qualified trial participants from the placebo group with minor symptoms such as a sore throat or a new cough. This is especially evident when a de facto unblinding among the trial participants has taken place, according to the petition.

From Rapid Microbiology news feed on July 20, 2020: He [Dr. Sin Hang Lee] has reported that the CDC tests generated 30% false-positive and 20% false-negative results at his laboratory. Sin Hang Lee re-tested 20 reference samples provided by the Connecticut State Department of Public Health Microbiology Laboratory Division to arrive at this conclusion, according to the published article.

Concerns and Recommendations of this Researcher

I am sure that this virus is serious, but I am saying that it is a virus and viruses, by definition, mutate as noted above.

Since mRNA technology has never been used in an FDA approved vaccine, long-term study is essential for safety. Otherwise, those who get vaccinated become the long-term study group.

I am also concerned that mainstream news is not emphasizing this fact and that the experimental mRNA vaccine is messaging our DNA/RNA without known results, especially long-term results.

Considering2 and 3 above,a requirement by any organization for its members to get the vaccination is unconscionable (in my opinion).

All participants in the trials have signed an “informed consent” which is understandable. Since there have been no long-term tests, informed consents should be obtained from all who choose to receive the vaccination. The informed consent should warn the patient that the drug company who produced the vaccine is not responsible for any Adverse Events.

Rather than emphasizing informed consent because of the lack of any long-term trial for an mRNA vaccine, the government, schools and medical businesses are pushing for a “required” policy.

Derek Lowe has acknowledged that viruses mutate which is why the flu vaccine is always different. Lowe said in an article on December 10, 2020, “And what’s going on, of course, is that the virus is mutating. It’s what viruses do.”Do we know that we are targeting an actual virus or are we guessing at the future? I do not know! Do they?

Most troubling to me is that there have been significantly fewer cases of flu reported by the CDC. Down 90% for clinical labs and down 99%+ for public health labs Or, is the flubeing reported as COVID?

There are way too many unanswered questions in this rush to a vaccine with the result that safety is being seriously compromised. We will explore this further in the next post.

 Michael D Hendrickson

Distribution with permission only, please!

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